COVID-19 treatment is active in domestic clinical

Immunemed's antiviral drug approved for therapeutic use

Abigan's emergency introduction has not yet been decided

As the number of Korean COVID-19 patients has soared, the development of therapeutics is also active.

 

In addition to multinational pharmaceutical company Gillead, domestic pharmaceutical company Komipharm has applied for clinical trial approval of the pipelines, and Immunemed's antiviral drug was approved for therapeutic use.

 

Gilead said that it will begin a clinical trial to research the efficacy and safety of Remdesivir in adult patients diagnosed with COVID-19.

 

The trial will evaluate two different dosing periods for Remdesivir.

 

In the first trial, approximately 400 COVID-19 patients with severe clinical features, will be randomized into the Remdesivir 5 or 10 day group.

 

In the second trial, approximately 600 patients with moderate COVID-19 will be randomized to the Remdesivir 5-day, 10-day, or standard therapy alone groups.

 

The primary evaluation variable in both trials is the same as the clinical improvement.

 

In multi-national trials, the number of subjects in Korea is unknown.

 

However, it is known that it recruits 1,000 people on a first-come, first-served basis.

 

The MFDS said that IND was received on the same day, and the exact information will be released after approval.

 

The MFDS plans to quickly approve clinical trials.

 

Remdesivir is a nucleotide analog pipeline that has shown extensive antiviral activity in vitro and in vivo animal models of new viral pathogens such as Ebola, MERS and SARS.

 

The symptoms improved with the first patient in COVID-19 in the United States, and is currently undergoing clinical trials in 761 patients in Wuhan, China.

 

Domestic companies also started to develop treatments.

 

Komipharm announced on the 26th that it has submitted IND application to KFDA to approve the clinical trial plan to expand the application of COVID-19 pneumonia from the new drug 'Panaphix', which is under development to suppress cytokines.

 

The company said the drug would treat the pneumonia caused by viral infections quickly and by inhibiting immune cell signaling factors and inhibiting the release of inflammatory cytokines TNF-α, IL-1β and IL-6.

 

The company emphasized that it has been effective in treating pneumonia, especially in animal studies and clinical trials involving 372 patients with other diseases.

 

The trial will include a total of 100 patients, 50 in each cohort.

 

The antiviral drug developed by Immunemed has been approved for emergency use in patients with COVID-19.

 

The MFDS explained to a COVID-19 confirmed patient who was admitted to Seoul National University Hospital on the 21st that they approved the use of the antiviral pipeline 'HzVSF v13' which is being developed by Immunemed.

 

The drug is known to have humanized the virus suppressing factor (VSF).

 

The company has been conducting Phase I clinical trials for influenza diseases since 2018.

 

If there is a therapeutic effect in patients receiving this agent, the possibility of full-scale clinical trials cannot be excluded.

 

The company, however, said it could not tell the question if it had benefited from patient administration.

 

Meanwhile, emergency introduction has not yet been decided on Abigan ( Favipiravir), which is being used as COVID-19 treatment in Japan.

 

In general, the use of the emergency introduction system to import domestic unlicensed items requires a request from the KCDC to the MFDS.

 

The MFDS official explained, however, that no request has been made so far, and it is currently being discussed with the central clinical trial committee.